Mining and analysis of adverse event signals for mavacamten based on FAERS
Objective To mine and analyze potential adverse drug event signals associated with mavacamten based on the FAERS,providing reference for clinical medication safety.Methods Using the online pharmacovigilance tool Open Vigil version 2.1,adverse drug event reports related to mavacamten in the FAERS database from April 1,2022,to September 30,2024,were collected.Data mining was performed utilizing the reporting odds ratio(ROR)and proportional reporting ratio(PRR)methods.Results After data cleaning,a total of 1 802 adverse drug event reports related to mavacamten were collected,identifying 43 valid adverse drug event signals.The most frequently occurring adverse drug event signals were consistent with those specified in the product labeling.Additionally,30 adverse drug event signals,including atrial fibrillation,nasopharyngitis,weight gain,urinary tract infection,and hypertension,were identified that were not mentioned in the product labeling.Conclusion When clinically applying mavacamten,it is crucial to not only monitor the adverse drug events explicitly listed in the product labeling but also to remain vigilant for unmentioned adverse drug events such as atrial fibrillation,nasopharyngitis,urinary tract infection,weight gain,and hypertension.Prior to and during treatment,patient LVEF should be monitored to prevent severe adverse reactions such as LVEF reduction and heart failure,ensuring medication safety for patients.
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